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A Pharmacology Primer, Third Edition: Theory, Application and Methods

This successful guide assists scientists trained in molecular biology and related fields who now need to know the basic theories, principles and practical applications of pharmacology. This latest edition continues the tradition of better preparing researchers in the basics of pharmacology. With expanded hands-on exercises and the addition of Pharmacokinetics coverage, new human interest material including historical facts in pharmacology and a new section on therapeutics that will help readers identify with diseases and drug treatments.

The ideal book for researchers in drug discovery who have seen their role shift from "individual" to "team player" where that team includes chemists, biologists, and others with strong, but varied, science backgrounds who must now work together toward their common pharmacology goal.

At GlaxoSmithKline, a pharmaceuticals world-leader, Terry Kenakin regularly teaches a course for their research scientists and has drawn on his experience to create a pharmacology primer.

*New - Latest coverage of the chemistry of drugs including expanded coverage of the pharmacokinetic discussion of druglike properties -- Increases reader understanding of necessary ADME (Absorption, Distribution, Metabolism, and Excretion) properties and increases the rate of drug approval and acceptance.

*Context - Unique discussions on various drug discovery teams and the role of the chemist on those teams -- Promotes the understanding of these expanding roles and responsibilities and how to maximize the effective contributions of each matrix team member.

*Real-world learning - There are hands-on exercises, with extensive answers, utilizing real data on structure activity relationships; utilization of pharmacological principles to make general statements about how changes in structure lead to changes in drug activity. + hands on exercises with extensive answers on Pharmacokinetics -- Stengthens practical application and understanding of core concepts and principles.

*Study sections are organized with ASPET (American Society for Pharmacology and Experimental Therapeutics)and other international organizations -- Ensures that learning follows professional industry standards.


Global Regulatory Issues for the Cosmetics Industry: Volume 1

The manufacture and use of cosmetics is an international undertaking unparalleled by any other industry. Regulation of this industry, however, is neither universal nor consistent. The purpose of this book (the first of a series) is to simplify the complex global Cosmetic Regulatory landscape by addressing the issues affecting the manufacture, packaging, and marketing of cosmetic products across the globe. Included are several chapters that examine the new European Union REACH regulation (Registration Evaluation and Authorization of CHemicals). Other chapters look at regulatory developments of individual countries, toxicity requirements, as well as how to develop a global regulatory strategy.


Clinical Pharmacokinetics: Concepts and Applications

Since pharmacokinetics can greatly affect how different patients respond to the same drug, both students and physicians need a basic clinical understanding of this vital area. The Third Edition of "Clinical Pharmacokinetics" provides a practical perspective, with these added features: considerations of both stereochemistry and the increasing number of polypeptide and protein drugs being developed; the range and number of problems at the end of each chapter has been expanded; a second color added to make the text more user friendly; and, important equations highlighted by shading.


Statistical Issues in Drug Development

Statistics in Practice A new series of practical books outlining the use of statistical techniques in a wide range of application areas:
* Human and Biological Sciences
* Earth and Environmental Sciences
* Industry, Commerce and Finance
Statistical Issues in Drug Development Stephen Senn Professor of Pharmaceutical & Health Statistics, University College, London Statistical Issues in Drug Development provides an accessible text for those working directly in drug development, regulatory and marketing departments within the pharmaceutical industry. As a consequence of regulatory authorities demanding increasingly higher standards, statistics has become a critical element in the design and conduct of drug development programmes. The concepts covered in this volume guide the non-statistician through the most pressing statistical issues and controversies in drug development. Key issues covered include:
* Design & interpretation of clinical trials
* Bayesian & frequentist methods
* Sequential & cross-over trials
* Drug monitoring & pharmaco-economics
The book has been prepared in two sections. The first section considers the role of statistics in drug development from four different perspectives: historical, philosophical, technical and professional. The second section covers a series of controversial topics such as fixed versus random effects for meta-analysis, one-sided versus two-sided tests and the ethics of placebo run-ins. The approachable and wide-ranging coverage of this book will make it invaluable to all those working in drug development and regulation.


Biopharmaceutical Process Validation

A study of biopharmaceutical process validation. It aims to enable developers and producers to ensure safe products, reduce the risk of adverse reactions in patients, and avoid recalls by outlining sophisticated validation approaches to characterize processes, process intermediates, and final product fully. The text emphasizes cost effectiveness while determining what level of validation is required for different phases of development, license application, and process improvements.


Pharmaceutical Dosage Forms: Tablets, Vol. 1

Complete in 3 volumes Pharmaceutics 18 Contributors. DNLM: 1. Dosage Forms.


Pharmaceutical Dosage Forms: Tablets, Vol. 3

Complete in 3 volumes. Pharmaceutical technology. 14 Contributors.

Drug Discovery: From Bedside to Wall Street

Everyone expects something from the drug industry. Physicians and patients, investors, regulators and administrators all have an active interest. Everyone wants to know what makes drugs 'work' medically and economically. Why are drugs so expensive? Is it the drug companies or investors who demand high profits? What governs the pharmacoeconomics? Why are so few diseases treatable? 

This book opens the windows and doors of the industry telling the story of drug development by using real stories from inside the process. 

* Co-written by Graham Lees and Tamas Bartfai who has been involved in the development of drugs taken by more that 20 million people every day 
* Opens the windows and doors of the most regulated industry in the world, the pharmaceutical industry 
* Tells the story of drug development by using real examples based on current research and events 
* Provides an objective, lucid account of the successes and failures, shortcomings and constraints of the pharmaceutical and biotech industries
* Gives insights into the development of new drugs to combat multiple conditions including cancer and pain 
* Balanced, unbiased account of how better to translate basic science into drug discovery.

Modern Industrial Microbiology and Biotechnology

This book is directed towards undergraduates and beginning graduate students in microbiology, food science and chemical engineering. Those studying pharmacy, biochemistry and general biology will find it of interest. The section on waste disposal will be of interest to civil engineering and public health students and practitioners. For the benefit of those students who may be unfamiliar with the basic biological assumptions underlying industrial microbiology, such as students of chemical and civil engineering, elements of biology and microbiology are introduced. The new elements which have necessitated the shift in paradigm in industrial microbiology such as bioinformatics, genomics, proteomics, site-directed mutation, metabolic engineering, the human genome project and others are also introduced and their relevance to industrial microbiology and biotechnology indicated. As many references as space will permit are included. The various applications of industrial microbiology are covered broadly, and the chapters are grouped to reflect these applications. The emphasis throughout, however, is on the physiological, biochemical principles, and where possible, the genomic principles behind these applications.


Pharmacy Management: Essentials for All Practice Settings, Second Edition

If it's important to your pharmacy career you'll find it here Covering everything from operations management and purchasing to Medicare Part D, this complete guide explains vital pharmacy management topics across all practice settings.
More than any other text, Pharmacy Management reflects the challenges facing today's pharmacist. The book is filled with advice from the field's top experts who take you through the principles applicable to all aspects of pharmacy practice, from managing money to handling personal stress. Long after you've taken your last pharmacy college exam, you'll turn to Pharmacy Management for answers to make your pharmacy practice more professionally rewarding and personally enriching.


A scenario-based presentation combines practical solutions with evidence-based management theory and models, which are directly applied to cases and examples. .
Learning objectives and QAndAs appear in every chapter.
NEW chapters on: Leadership, Medicare Part D, and Financial Reports.
Important revisions to the chapters on Managing Technology and Information Systems and Reimbursement for Value-Added Pharmacy Services.

Analytical Measurement Terminology: Handbook of Terms Used in Quality Assurance of Analytical Measurement

This unique handbook explains the most commonly used terminology and places each term in context. Concepts are described in a way that make them meaningful to practitioners and in line with "official definitions" developed by international organizations.

Sterilisation of Polymer Healthcare Products

"The use of polymers in medical technology continues to grow and provides major business opportunities for companies who service the medical industry. Sterilisation has always been challenging but sterilisation of polymer healthcare products is an even greater challenge - how do you sterilise without adversely affecting the end use or the end user? This comprehensive reference supplies insights into this developing field.

Sterilisation of Polymer Healthcare Products offers a thorough description of the conventional methods of ethylene oxide, gamma and electron-beam radiation, steam and dry heat sterilisation as well as covering newer methods such as hydrogen peroxide/plasma, gluteraldehyde, steam - formaldehyde, peracetic acid, chlorine dioxide and ozone.

With the many possible ways to sterilise healthcare products, and new techniques being developed all the time, the author identifies the variety of factors and functions that must be taken into account, such as the requirement for an understanding of physical, chemical and biological properties, design and manufacturing processes, quality control and regulatory issues.

This book discusses the evaluation of candidate materials and components for compatibility with the different sterilisation methods. From this point methods may be chosen and materials screened for biocompatibility, devices manufactured and samples tested, and a validation process chosen.

Sterilisation of Healthcare Products is a necessary and worthwhile reference for medical device manufacturers and polymer suppliers, as well as purchasing and quality assurance managers in the healthcare industry. It is designed to be of use to anyone already working in the field of sterilisation of healthcare products but it will be equally useful to someone about to start working in the field. "

Pharmaceutical Engineering - Jan/Feb 2009


  • Fundamentals of Bacterial Adhesion Applied Toward Infection Prevention: Focus on Two Case Studies
  • ISPE Update
  • Classified Advertising
  • Advertiser’s Index
  • Online Total Organic Carbon (TOC) as a Process Analytical Technology for Cleaning Validation Risk Management Using Visible Residue Limits for Cleaning
  • Industry Interview Series: Senior Staff Members from China’s State Food and Drug Administration (SFDA)
  • Beyond the Bell Curve: A Report on Managing Capital Project Risk

Quality and Costs

This section discusses how quality has an impact on the costs of goods and services in an organization.Section 7, Quality and Income,addresses the issue of quality and sales revenue. Thus, the two sections provide a framework of how quality is related to the total financial picture of an organization. We identify and measure the costs associated with poor quality for three reasons: to quantify the size of the quality problem to help justify an improvement effort, to guide the development of that effort, and to track progress in improvement activities. Among the concepts and methodologies covered are traditional categories of quality costs, a broadened concept of categories including lost revenue and process capability costs, activity-based costing, data collection methods, return on quality, presentation of findings, gaining approval for an improvement effort, using cost data to support continuous improvement, optimum quality level, and reporting cost data. The underlying theme in the section is the use of quality-related costs to support a quality improvement effort rather than as a system of reporting quality costs.

Developing Solid Oral Dosage Forms: Pharmaceutical Theory&Practice

This book is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with:

Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms 

Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies 

New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development 

The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards 

It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter 

A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies.

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Fundamentals of Clinical Research - Statistics for Biology and Health

In recent years many introductory textbooks on clinical trial methodology have been published, some of which are excellent, in addition to a very extensive specialist literature. Nevertheless, here is a new book on methods and issues in clinical research. The objectives can be summarized in three points.

1. Integrate medical and statistical components of clinical research. 
2. Do justice to the operational and practical requirements of clinical research. 
3. Give space to the ethical implications of methodological issues in clinical research.

The scope of clinical research is to evaluate the effect of a treatment on the evolution of a disease in the human species. The treatment can be pharmacological, surgical, psychological/behavioral or organizational/logistic. The disease, intended as an impairment of a state of well-being or a condition capable of provoking such impairment over time, can be universally accepted as such (e.g. a cancer or a bone fracture) or perceived as such only by limited groups of individuals in a given cultural context (e.g. hair loss or weight gain). The course of the disease that ones wishes to change can be the one with no intervention or, more frequently, the one observed with the available treatment. The evaluation of the effect of a treatment on the course of a disease is a lengthy process, which progresses in increasingly complex stages.

A detailed coverage of the logistic, administrative and legal aspects of clinical research is outside the scope of this book. However, throughout the book we keep reminding the reader of these aspects because, as already mentioned, we firmly believe they have a crucial role in determining the success of a study. The history of clinical research is paved with relics of studies started with great pomp, riding great ideas and great hopes, which drowned miserably because of inadequate logistical preparation. In our experience, the excessive complexity of a clinical trial is the single most frequent cause of failure: the study is perfect on paper, but impossible to implement by patients and staff alike. The distance between the principal investigators and the reality of clinical research in its day-to-day practice is often the main cause of such disasters. We warmly encourage everyone involved in clinical research to get involved in the logistics of a study, learning from colleagues responsible for its practical conduct (clinical research associates, data managers, etc.) and to take part, in person, in the practical implementation of a trial before attempting to design a study protocol.

The book ends with a brief description of the drug development process and to the phases of clinical development.

Particulate Interactions in Dry Powder Formulation for Inhalation

Interactions between drug particulates are crucial in determining drug dispersion and deaggregation, and ultimately delivery efficiency. This book combines principles and factors in pharmaceutical powder technology, critically reviews some of the studies carried out in dry powder formulation development, and proposes possible strategies for improving their efficiency. The majority of these principles are applicable to other pharmaceutical solid dosage forms (e.g. tablets and capsules).

Development of Biopharmaceutical Parenteral Dosage Forms

This up-to-the-minute reference delineates;in a systematic fashion;the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products;covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.


Drug Products for Clinical Trials: An Intl Guide to Formulation, Production, Quality Control

This practical guide shows how the appropriate use of clinical materials can increase efficiency in bringing new products to the marketplace;offering authoritative assessments of the scientific and legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies. The only wide-ranging, up-to-date book of its kind available on the subject! Describing both the science and management of product development, Drug Products for Clinical Trials furnishes effective approaches for preclinical drug discovery addresses the function of the clinical trials materials manager covers the design of clinical protocols in developing a new chemical entity (NCE) explains the importance of bioequivalence between clinical trials materials and final products demonstrates rapid, reliable processes for clinical evaluation discusses the interaction between clinical research, manufacturing, and packaging reviews quality control strategies used in the manufacture of drug substances for clinical studies conducted throughout the world and much more!

Safety Pharmacology In Pharmaceutical Development And Approval

Providing detailed coverage of an emerging discipline within the pharmaceutical industry, Safety Pharmacology in Pharmaceutical Development and Approval lays out exactly the whys and hows of safety pharmacology testing. The book covers the background, history, and concerns that have evolved from lackluster safety pharmacology activities in the past. It details regulatory requirements, provides comprehensive information on study designs, and covers both the required battery of studies and the supplemental, follow-up battery. The author addresses how best to implement ICH safety standards and how to integrate pharmacology safety evaluations into existing safety evaluations.

Good Laboratory Practice Regulations Vol 69

Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation.

Pharmaceutical Biotechnology

The textbook on Pharmaceutical Biotechnology provides comprehensively the fundamental concepts and principles in Biotechnology to expatiate and substantiate its numerous modern applications with regard to the spectacular development in the Pharmaceutical Industry. In a broader perspective, the students studying Biotechnology at undergraduate and postgraduate levels shall be grossly benefited by its well-planned systematically developed, structured, illustrated, expanded, elaborated, and profusely exemplified subject matter.It essentially comprise five major chapters, namely: Immunology and Immunological Preparations; Genetic Recombination; Antibiotics; Microbial Transformations; and Enzyme Immobilization. Besides, there are five auxiliary chapters, namely, Advent of Biotechnology; Biosensor Technology; Bioinformatics and Data Mining; Regulatory Issues in Biotechnology; and Safety in Biotechnology, which have been specifically included so as to stimulate the students, interest and broaden their horizon of knowledge and wisdom.The authors earnestly believe that the wide coverage of various topics mentioned above would certainly render Pharmaceutical Biotechnology to serve as an exclusive source of information`s, ideas, inspirations towards research, and finding newer possible practical solutions to problems encountered in the ever green pasture using knowledge of Biotechnology in the Pharmaceutical Industry. Contents Immunology and Immunological Preparations
Genetic Recombination
Microbial Transformations
Enzyme Immobilization
Advent of Biotechnology
Biosensor Technology
Bioinformatics and Data Mining
Regulatory Issues in Biotechnology
Safety in Biotechnology


Advances in Chromatography, Volume 35

The rapidly expanding growth of the literature on chromatography, capillary electrophoresis, field flow fractionation, and other separation techniques makes it difficult for any individual to maintain a coherent view of progress in the field. Rather than attempt to read the avalanche of original research papers, investigators trying to preserve even a modest awareness of advances must rely upon authoritative surveys. Featuring reliable, up-to-the-minute reviews of major developments in chromatography and other separation techniques, this critically praised series separates the most important advances from an overabundance of supplementary materials.


Impurities Evaluation of Pharmaceuticals

Filling a gap in the pharmaceutical literature, this unique guide addresses the development of targeted methodologies to monitor impurities in pharmaceutical compounds and drug products. Furnishes physicochemical protocols to determine the purity of pharmaceutical compounds fully before pharmacological and toxicological studies begin! Providing a clear definition of the subject, Impurities Evaluation of Pharmaceuticals introduces various techniques for isolating and characterizing impurities presents guidelines to evaluate stability using kinetic studies shows how to develop stability-indicating methodologies details various methods that require minimal sample prepreparation gives regulatory perspectives on chiral impurities and more! Containing important literature citations and offering an invaluable list of applications, Impurities Evaluation of Pharmaceuticals is an outstanding resource for pharmacists and pharmacologists, clinical microbiologists, quality assurance and production managers in the pharmaceutical industry, analytical chemists and biochemists, pharmaceutical regulatory personnel, and upper-level undergraduate, graduate, and continuing-education students in these disciplines.


Indoor Air Quality: A Guide for Facility Managers

Written in easy-to-understand, non-technical terms, this book can be both a ready reference and training guide. Covering each type of indoor air hazard, the author explains the basics of proper ventilation and the relationship of the HVAC system to indoor air quality. He examines fundamental procedures for maintaining good air quality, including filtration, control of humidity and moisture, and duct cleaning. A full chapter is devoted to recent developments and procedures for controlling toxic mold. Case studies, an HVAC glossary, and several helpful directories are also included. The guide provides a comprehensive account of indoor air quality hazards, their sources, and appropriate solutions.